Infant Bacterial Therapeutics AB announced on 3/5/19 the first distribution agreement for IBP-9414 with Megapharm Ltd. for the Israeli market and the Palestinian Authority’s territories. The agreement gives MegaPharm exclusive rights to market and sell the product, if and when the product receives market approval, after the pivotal clinical phase III trial that is expected to start during the current half year. MegaPharm will handle the registration, price negotiations as well as manage marketing and all of the practicalities that distribution of a pharmaceutical entails.
IBT is developing drug candidate IBP-9414 to prevent necrotizing enterocolitis (NEC), a devastating and often fatal disease in premature infants. IBP-9414 contains the active substance Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. IBT has an additional project in its portfolio, a second rare disease program, IBP-1016, for the treatment of an unmet medical need in gastroschisis, a severe disease in infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.
IBT has chosen to establish a distribution agreement, and not a license agreement with significant up-front payments, in order to obtain a larger share of future sales revenue. IBT’s share will, after an initial shorter period, account for 70% of revenues.
As the Israeli health service offers advanced medical care for premature babies, IBT plans to open clinical trial centers for the pivotal phase III trial in the country. Megapharm is already participating in this work as it is essential to engage “key opinion leaders” in the marketing of the product.